RecruitingNCT07054177

Metabolic Profiling of Saliva in Pregnancy and Periodontal Disease

Salivary Metabolomics of Pregnancy and Periodontal Disease Related Metabolic Pathways


Sponsor

Bezmialem Vakif University

Enrollment

30 participants

Start Date

Jun 24, 2025

Study Type

OBSERVATIONAL

Conditions

Summary

This study aims to better understand how pregnancy affects the health of the gums and tissues that support the teeth. During pregnancy, hormone levels (like estrogen and progesterone) increase significantly. These hormonal changes can cause many changes in the body, including in the mouth. Some pregnant women may notice that their gums become swollen, red, or bleed more easily - this is called pregnancy gingivitis. It happens more often during the second and third trimesters and usually improves after birth. Even if a pregnant person has good oral hygiene, hormonal changes may still make the gums more sensitive to plaque and bacteria. Scientists believe that these changes in gum health are linked to how the body responds to hormones, bacteria in the mouth, and changes in the immune system. To explore this further, saliva samples will be collected from: * Pregnant women during their 1st, 2nd, and 3rd trimesters * The same women again 6-8 weeks after giving birth * A group of non-pregnant, healthy women as a comparison group The investigators will use a scientific method called untargeted metabolomics to study these saliva samples. This method helps looking at small substances (called metabolites) in saliva to see if there are any patterns related to pregnancy and gum health. The goal is to identify biological changes that happen during pregnancy and understand how they might affect the gums. This research will help improve early detection and prevention of gum problems during pregnancy in the future.


Eligibility

Sex: FEMALEMin Age: 18 YearsMax Age: 40 Years

Inclusion Criteria13

  • Age between 18 and 40 years
  • No history of systemic disease or chronic infection
  • No use of antibiotics or anti-inflammatory drugs in the last 3 months
  • Non-smoker and non-alcohol user
  • Willingness to participate by signing the informed consent form
  • Additional Criteria for Pregnant Volunteers:
  • Singleton pregnancy (no multiple gestation)
  • Pregnancy progressing without complications (e.g., no diagnosis of preeclampsia, gestational diabetes, or threatened preterm labor)
  • Gestational age confirmed by ultrasound
  • Additional Criteria for Non-Pregnant Control Group:
  • No history of pregnancy in the past 6 months
  • Regular menstrual cycles
  • No history of hormonal disorders (e.g., polycystic ovary syndrome, thyroid dysfunction)

Exclusion Criteria8

  • Use of anti-inflammatory or antimicrobial treatments in the past 3 months
  • Smoking or alcohol consumption
  • Body mass index (BMI) \> 30 kg/m²
  • Presence of systemic diseases including diabetes mellitus, hyperprolactinemia, congenital adrenal hyperplasia, androgen-secreting tumors, thyroid dysfunction, Cushing's syndrome, hypertension, liver or kidney dysfunction
  • Use of medications that may affect metabolic or hormonal parameters, such as oral contraceptives, steroid hormones, antihypertensives, or insulin-sensitizing drugs
  • Periodontal treatment in the past 6 months
  • Use of medications known to affect periodontal status (e.g., phenytoin, calcium channel blockers, cyclosporine, warfarin, NSAIDs, aspirin \> 81 mg)
  • Active infectious diseases such as hepatitis, HIV, or tuberculosis

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Locations(1)

Bezmialem Vakıf University, Faculty of Dentistry and Faculty of Medicine, Istanbul

Istanbul, Fatih, Turkey (Türkiye)

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NCT07054177


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